Two novel products are being launched to compete in the $21 billion-per-year global insulin market.
A review committee of the European Medicines Agency has recommended approval of an investigational insulin compound developed jointly by Eli Lilly & Co. and Boehringer Ingelheim that would be the first biosimilar version of long-acting insulin sold in Europe.
The compound is a basal glargine insulin, a glycemic control agent intended to regulate blood sugar at night and between meals. It has the same amino acid sequence as Sanofi’s patented drug Lantus.
The review committee’s recommendation is based on Phase III studies in patients with types 1 and 2 diabetes, as well as other data. A final decision by the European Commission is expected within two months. Europe is currently the only market with a protocol for the approval of biosimilars, which are generic versions of biologic drugs.
“This is a move to weaken Sanofi’s stranglehold on the market for long-acting insulin,” says Lisa Urquhart, an editor at market analyst firm Evaluate in London. But the impact will be limited, she says, since Europe accounts for only 15% of worldwide sales for Lantus, which totaled $7.6 billion last year.
Meanwhile, MannKind is advancing into inhalable insulin, territory from which Pfizer withdrew after a short foray in 2007. The California firm’s Afrezza, approved by FDA last week, is a glycemic control agent for adults with diabetes. Pfizer’s Exubera was a similar powder form of insulin, but the company withdrew it from the market within a year owing to poor sales.
A MannKind spokesman notes that Afrezza uses a whistle-sized inhaler that is much smaller than the 12-inch-long device that delivered Exubera. “Additionally, we have had the opportunity to study and learn from the marketing challenges faced by Exubera,” he says.
Urquhart acknowledges the advantage of MannKind’s smaller device but still sees a significant challenge to sales. “I think people will be wary about having huge amounts of insulin dumped into their lungs,” she says. “That questions how big the market is actually going to be, considering how we have got very good pen devices for injectable insulin. This market might be for the needle-phobic.”